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LOS ANGELES, CA - (NewMediaWire) - September 26, 2024 - Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), announced an upcoming meeting with the U.S. Food and Drug Administration (“FDA”) leadership to discuss lead candidate CNM-Au8^®.

●      The company is seeking an accelerated approval regulatory pathway for CNM-Au8^® for ALS.

●      The FDA agreed to an in-person meeting to reevaluate Clene’s submission.

●      Lead drug candidate CNM-Au8 has been shown to restore and protect neurological function, offering hope for patients with neurodegenerative conditions.

●      The FDA meeting will be held before the end of November and will be attended by top FDA officials and key opinion leaders in ALS, biostatistics and biomarkers.

According to a company press release, the in-person meeting will be held before the end of November 2024 and will focus on the company’s CNM-Au8 biomarker and related clinical and survival data for ALS. The meeting will be attended by FDA’s Director of the Office on New Drugs, the Director of the Office of…

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Forward-Looking Statements

Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management’s control, including the risks set forth under the heading “Risk Factors” discussed under the caption “Item 1A. Risk Factors” in Part I of the Company’s most recent Annual Report on Form 10-K or any updates discussed under the caption “Item 1A. Risk Factors” in Part II of the Company’s Quarterly Reports on Form 10-Q and in the Company’s other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.

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